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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01373-44 | Other Identifier | RCB number |
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The main objective of this study is to evaluate whether acceptance (measured by the AAQ-II questionnaire) is prognostic of algo-functional changes measured by the Oswestry Disability Index, ODI) at 6 months.
The secondary objectives are:
A. To search for correlations between the acceptance score (AAQ-II Questionnaire) and scores for coping (CSQ), avoidance (FABQ), understanding (BBQ), anxiety and depression (HADS) and quality of life (SF-12) at baseline.
B. To describe the kinetics of changes in various parameters (acceptance, coping, avoidance, understanding, anxiety and depression, quality of life, ODI) over 6 months.
C. To evaluate the agreement between two methods of questionnaire presentation: Paper collection versus collection by Tablet PC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar spine pain inpatients | The study population corresponds to inpatient rehabilitative care for lumbar spine pain in the Departments of Physical Medicine and Functional Rehabilitation at the Nîmes and Montpellier University Hospitals. |
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| Measure | Description | Time Frame |
|---|---|---|
| Classification of the patient as a responder or a non responder | The response to treatment will be evaluated by the ODI (Oswestry Disability Index) at 6 months: a patient will be considered as a responder when the absolute change between the score at 6 months and inclusion is at least 10 points (Ostelo RW et al., 2008). This outcome is a qualitative variable with two options: responder or non-responder. The fact that we define in an apriori fashion who is a responder or not does not mean that we have created multiple outcomes. This is a single outcome. | 6 months |
| Acceptation and Action Questionnaire - II (AAQ-II) score | Day -7 (inclusion) |
| Measure | Description | Time Frame |
|---|---|---|
| the AAQ-II Score | Day 0 | |
| the AAQ-II Score | Month 1 | |
| the AAQ-II Score |
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Inclusion Criteria:
Exclusion Criteria:
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The study population corresponds to inpatient rehabilitative care for lumbar spine pain in the Departments of Physical Medicine and Functional Rehabilitation at the Nîmes and Montpellier University Hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud Dupeyron, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Month 3 |
| the AAQ-II Score | Month 6 |
| Oswestry Disability Index | Day -7 |
| Oswestry Disability Index | Day 0 |
| Oswestry Disability Index | Month 1 |
| Oswestry Disability Index | Month 3 |
| Oswestry Disability Index | Month 6 |
| Coping Strategies Questionnaire in French (CSQ-F) | Day -7 |
| Coping Strategies Questionnaire in French (CSQ-F) | Day 0 |
| Coping Strategies Questionnaire in French (CSQ-F) | Month 1 |
| Coping Strategies Questionnaire in French (CSQ-F) | Month 3 |
| Coping Strategies Questionnaire in French (CSQ-F) | Month 6 |
| The Back Beliefs Questionnaire | Day -7 |
| The Back Beliefs Questionnaire | Day 0 |
| The Back Beliefs Questionnaire | Month 1 |
| The Back Beliefs Questionnaire | Month 3 |
| The Back Beliefs Questionnaire | Month 6 |
| The Fear-Avoidance Beliefs Questionnaire | Day -7 |
| The Fear-Avoidance Beliefs Questionnaire | Day 0 |
| The Fear-Avoidance Beliefs Questionnaire | Month 1 |
| The Fear-Avoidance Beliefs Questionnaire | Month 3 |
| The Fear-Avoidance Beliefs Questionnaire | Month 6 |
| The Hospital Anxiety and Depression Scale | Day -7 |
| The Hospital Anxiety and Depression Scale | Day -0 |
| The Hospital Anxiety and Depression Scale | Month 1 |
| The Hospital Anxiety and Depression Scale | Month 3 |
| The Hospital Anxiety and Depression Scale | Month 6 |
| The SF-12 questionnaire | Day -7 |
| The SF-12 questionnaire | Day 0 |
| The SF-12 questionnaire | Month 1 |
| The SF-12 questionnaire | Month 3 |
| The SF-12 questionnaire | Month 6 |
| Average pain over the last 8 days measured via visual analog scale. | Day -7 |
| Average pain over the last 8 days measured via visual analog scale. | Day 0 |
| Average pain over the last 8 days measured via visual analog scale. | Month 1 |
| Average pain over the last 8 days measured via visual analog scale. | Month 3 |
| Average pain over the last 8 days measured via visual analog scale. | Month 6 |
| Maximum pain over the last 8 days measured via visual analog scale. | Day -7 |
| Maximum pain over the last 8 days measured via visual analog scale. | Day 0 |
| Maximum pain over the last 8 days measured via visual analog scale. | Month 1 |
| Maximum pain over the last 8 days measured via visual analog scale. | Month 3 |
| Maximum pain over the last 8 days measured via visual analog scale. | Month 6 |
| Nîmes |
| 30029 |
| France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |